| CTRI Number |
CTRI/2021/08/035331 [Registered on: 02/08/2021] Trial Registered Prospectively |
| Last Modified On: |
31/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Assessing the Feasibility and Impact of Physical Health Monitoring in Patients with First Episode Psychosis (AIIMS centre) |
|
Scientific Title of Study
|
Assessing the Feasibility and Impact of Physical Health Monitoring in Patients with First Episode Psychosis (AIIMS centre) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rakesh Kumar Chadda |
| Designation |
HOD Dept Of Psychiatry and NDDTC AIIMS |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no 4084
4th floor
Teaching block
Dept of psychiatry
New Delhi
South
DELHI
110029
India |
| Phone |
011-26593245 |
| Fax |
|
| Email |
drrakeshchadda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Kumar Chadda |
| Designation |
HOD Dept Of Psychiatry and NDDTC AIIMS |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no 4084
4th floor
Teaching block
Dept of psychiatry
New Delhi
South
DELHI
110029
India |
| Phone |
011-26593245 |
| Fax |
|
| Email |
drrakeshchadda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rakesh Kumar Chadda |
| Designation |
HOD Dept Of Psychiatry and NDDTC AIIMS |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no 4084
4th floor
Teaching block
Dept of psychiatry
New Delhi
South
DELHI
110029
India |
| Phone |
011-26593245 |
| Fax |
|
| Email |
drrakeshchadda@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute for Health Research ,U.K. |
|
|
Primary Sponsor
|
| Name |
National Institute for Health Research |
| Address |
National Institute for Health Research
Evaluation, trials and Studies Coordinating Centre
University of Southampton
Alpha House, Enterprise Road
Southampton, SO16 7NS |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RAKESH KUMAR CHADDA |
Out-patient settings, Department of Psychiatry, AIIMS, New Delhi |
ANSARI NAGAR, NEW DELHI
South
DELHI |
011-26593245
drrakeshchadda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (2) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (3) ICD-10 Condition: F20||Schizophrenia, (4) ICD-10 Condition: F22||Delusional disorders, (5) ICD-10 Condition: F23||Brief psychotic disorder, (6) ICD-10 Condition: F25||Schizoaffective disorders, (7) ICD-10 Condition: F28||Other psychotic disorder not due to a substance or known physiological condition, (8) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Booklet-based intervention arm |
Psychoeducation booklets and physical health monitoring used to provide psychosocial intervention for three months. Assessment will be done at baseline, 1 month and 3 months |
| Intervention |
Mobile-app based intervention arm |
Mobile app developed for physical health monitoring and psychoeducation. Intervention with mobile app will be provided for three months. Assessment will be done at baseline, 1 month and 3 months |
| Comparator Agent |
Treatment as usual arm |
Standard routine care given at AIIMS, New Delhi. No additional intervention will be given. Assessment will be done at baseline, 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for Patient
ï‚· First presentation with psychotic symptoms at our centre
ï‚· Age 14-45 years
ï‚· No past history of psychosis
 Not received treatment ≥ 3 months
ï‚· Either sex
ï‚· Schizophrenia (F20), persistent delusional disorder (F22), acute and transient psychotic disorders (F 23), Schizo-affective disorder (F25), Other and Unspecified Psychosis (F28 & F29), Mania with psychotic symptoms (F30.2), Bipolar affective disorder, current episode manic with psychotic symptoms (F 31.2), Severe depressive
episode with psychotic symptoms (F32.3) and Recurrent Depressive Disorder, current episode depression with psychotic symptoms (F 33.3) on ICD-10 (WHO 1993).
Inclusion criteria for Caregiver
A family member staying with patient and fulfilling any three of the following criteria (Maji et al, 2012):
ï‚· Parent or spouse
ï‚· Had most frequent contact with the patient
ï‚· Helped to support the patient financially
 Had most frequently been a participant in patient’s treatment
ï‚· To be contacted by treatment staff in case of an emergency |
|
| ExclusionCriteria |
| Details |
Exclusion criteria for Patient
ï‚· Presence of pervasive developmental disorder, specific learning disability and mental retardation (ascertained on history and clinical examination)
ï‚· Presence of organic brain damage, epilepsy (ascertained on history and clinical examination)
ï‚· Not willing or able to provide informed consent
Exclusion criteria for Caregivers
ï‚· Not willing/or able to provide informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SAPS,SANS, YMRS, MADRS,BPRS, GAF, SOFAS, EQ 5 D 5L, Assessment of Physical Health Checklist
Weight, Height, BMI, Waist Circumference, Hip Circumference, Waist–to-Hip Ratio, Blood Pressure
-Laboratory Investigations: ECG, haematology, liver function test, kidney function test, urine examination (for proteinuria and microalbuminuria), lipid profiling, fasting glucose and fasting insulin ( for Insulin Resistance ), HbA1C
|
baseline, 1 month, 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Food taking patterns
Feasibility performa |
baseline, 1 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a multicentric multicountry project funded by National Institute for Health Research, UK titled multicentric multicountry project funded by National Institute for Health Research, UK titled “NIHR Global Health Research Group on Psychosis Outcomes: the Warwick-India- Canada (WIC) Network, The University of Warwickâ€.The objectives of the project at AIIMS center are to determine prevalence of cardiometabolic risk factors such as metabolic syndrome, insulin resistance, prediabetes in a cohort of FEP patients and to assess feasibility and acceptability of using mobile app and booklet based psychosocial intervention protocols in patients with FEP in promoting adherence to healthy lifestyle and impact on outcomes (psychopathology, food taking patterns, physical activity and physical health parameters, functioning and quality of life).The Project aims to improve the physical health, wellbeing and functioning, and reduce the burden for patients with first episode psychosis. It aims to do this by applying using mobile app and booklet based psychosocial intervention protocols in patients with FEP. |